WO2004009149A2

WO2004009149A2 - Device for protecting a needle-type invasive element

Info

Publication number: WO2004009149A2
Application number: PCT/FR2003/002300
Authority: WO
Inventors: Pierre Lahlou Khalid
Original assignee: Biofront
Priority date: 2002-07-19
Filing date: 2003-07-21
Publication date: 2004-01-29
Also published as: FR2842429A1; EP1525016A2; AU2003271822A1; EP1525016B1; WO2004009149A9; AU2003271822A8; WO2004009149A3; ATE533525T1

Abstract

The invention concerns a device (10) for protecting a needle-type invasive element (20) comprising an end tip, characterized in that it comprises a thin single-piece element, including a part (14) to be anchored for example to the invasive element spaced from the tip and a part (16) for protecting the tip, the thin element being configured such that it can adopt two stable positions, one first position wherein the protective part covers the tip, and a second position wherein the protective part is cleared from the tip enabling invasion. The device can co-operate with a needle mounted on a device designed to contain fluid, in particular for injecting a therapeutic liquid or for sampling a body fluid. The invention is characterized in that it comprises a part for mounting the invasive element, defining a global axis of the device, and a single-piece sheath deformable essentially along said axis.

Description

The present invention relates generally to medical injection devices.

The medical injection needle is currently the most widely used means for puncturing body fluids and for inoculating or infusing therapeutic substances in the tissues of patients, on an ad hoc or long-term basis. In the case of a syringe, it is coupled to a pump body provided with a piston and constitutes the best known of the injection devices. The coupling between the pump body and the needle has long been standardized.

The concept of the syringe is more than a hundred years old and its last revolution was the transformation and the implementation of plastic materials in substitution for glass. This made it possible to generalize the use of disposable syringes. However, pre-filled syringes in a rapidly developing market have benefited little from this technical development. Today the high performance of this material ensures the barrier effect function hitherto reserved for glass.

New high-performance plastic technology has already made it possible to preserve the injectable liquid content from oxidation due to minute gas exchanges, through the slightly porous walls of the container.

This is the multilayer film technology. Its cost of implementation is however very high.

Furthermore, if a single use of the disposable syringe is an improvement in hygiene, it is not in itself a guarantee against the risks of contamination by the HIV virus or others, because although manufactured to be disposable, the syringes and needles keep all their functionality after first use. Reuse is one of the sources of the spread of the AIDS epidemic in certain populations who are more exposed or have low purchasing power. The present innovation aims to bring an improvement in the efficiency of the injection devices. As for the needle, an invasive means essential for medical injection, it is known for its effectiveness. Thus a medical injection can be subcutaneous, intradermal, intramuscular or intravenous or even, the needle can be used to take samples of bodily fluids or lumbar or mammary punctures for example.

Disregarded for its disadvantages such as the apprehension of pain or the risk of transcontamination, the needle still offers the best cost / effectiveness ratio which is itself the best guarantee of the sustainability of its use, and we will see that the The invention is not intended to call it into question. Thus, despite the emergence of new needleless inoculation means, rare are the biological vectors capable of carrying elements such as a protein, a peptide, a gene fragment or any other active principle without the aid of a instrument or injection device for crossing the skin barrier.

However, it will also be seen that nothing prevents the implementation of the invention with such new biological vectors.

Still on the subject of the injection needle, recent bevel sharpening techniques and single use, which allow you to benefit from the cutting edge optimal, significantly reduced the pain of the bite, but at the same time increased its dangerousness.

Yet another object of the invention is to improve the safety of practitioners by offering them integrated protection against the risks of accidental injection which can be the source of very feared contaminations in environments with a high viral load.

In this regard, the main constraints encountered to improve safety are of an economic and industrial nature, in addition to, of course, compliance with good operating practice involving adapting to the gestures and professional habits of health workers, and the invention aims to satisfy all of these constraints. In addition, the invention aims to deal by the same means with the diversity of needles existing on the market. In this regard, it will be seen that the invention makes it possible to overcome the well-known limit of the cost-effectiveness ratio taking into account the investments for launching new products and the exhaustion of the fields of productivity in the sector, and of the resistance to the change of health workers concerning professional gestures.

In this regard, the standardization of the needle / syringe coupling has certainly favored the importance of series and therefore the drop in production costs, but there does not seem to be any needle securing technique which does not call into question these normative provisions. On the industrial level, the medical injection needle is a very large series consumable. Its usage is estimated at one thousand units per second in the world. It is therefore a mass market with a particularly high access barrier, given the investment required in machines whose production rates can reach 120 units / second. Yet another object of the invention is to provide a new injection device which remains easily industrializable.

A medical injection device according to the invention may, as mentioned above, cooperate with an injection needle, sold as a sterile, disposable, single-use, disposable accessory, individually wrapped to be coupled, in a manner known per se, for example to a syringe or else to a vacuum container to allow punctures for analysis or even to an infusion or infusion system.

The diameter of the needle and its length are standardized according to the nature of the medical procedure. Its size (length, diameter) and the length of its LB bevel are matched to each specific medical procedure. The international unit of measurement that defines this size is the Gauge according to the AG (American Wire Gauge) system, a universal ISO 6009 color code allowing visual and rapid recognition of the ad hoc size. For example one. “21 G ^” caliber intramuscular injection needle is approximately 39 to 40 mm long and 0.80 or 0.90 mm in diameter. Its distinctive color is green for the 0.80 mm diameter and yellow for the 0.90 mm diameter. A pigment colored throughout the plastic material constituting the female Luer cone forming the base of the needle. This female Luer cone forms the coupling base with standard dimensions with the male Luer cone of any type of syringe complying with the standard and more generally with any standard series device IV. The cannula is usually coated with a silicone film to facilitate penetration into the tissues. Mating is done by wedging according to Morse law, at an angle of about 6 °. We will describe below, in the context of additional functions of the safety device according to the invention, how this wedging can be reinforced to dissuade anyone from making a second use of the injection device.

Typically, a device according to the present innovation will relate more particularly to needles of gauge 19 to 27 Gauges and whose length varies between 12 and 30 mm. This collection includes the range of fine needles whose diameter is between 0.40 and 0.60 with short bevel or long bevel, dedicated to hypodermic use, and the range of needles dedicated to the removal of bodily fluids from short bevel and whose outside diameter is greater than or equal to 1 mm. Protecting the invasive tip is essential during the different phases of needle use to meet different safety needs. This integrated protection became compulsory according to American legislation since April 2001, date of entry into force of the law known as "Needle Stick Prevention Act" promulgated in November 2000.

During the procedure, the invasive tip of the needle can be altered as soon as it is out of its protective cover. In the event of alteration, severe pain ensues during penetration into the patient's skin. During the act this tip can cause accidental contamination. It can be similarly if the instrument is negligently abandoned on the public highway by rather inconsistent or unconscious users.

During the first phase, before the bite, it is essential to ensure that the cutting edge is never in contact with a hard part which could slightly dull it, it being understood that the shape, the sharpness of the point as well as the edge of the bevel have the common objective of piercing the epidermis in the least painful way possible.

During the second phase, during the actual operating procedure, the point must be able to be released to allow penetration at angles, depths and visibility specific to the nature of the planned procedure. The safety device in the operating position must be stable and not hinder the masterful execution of the operating act.

After injection or sampling (third phase), the proliferation of accidents due to accidental needlestick imposes that the soiled end must be protected during various manipulations; the same applies if the instrument is used outside of a hospital context.

Although it is compulsory to have, wisely, special containers for the collection of used needles and syringes, it is clear that the effectiveness of the containerization system depends on the discipline of health workers and not on a physical law specific to the mechanical constraints assigned by the manufacturer to the protection of persons against the risk of contamination. The same applies to so-called single-use syringes, pre-filled or not, equipped an original needle. As the use of such syringes is spreading more and more outside the dispensary context, it is essential that a protection integrated into the needle and activating itself prevents accidental injections. This prevention is particularly necessary for people not warned of the danger and exposed by the nature of their job or their occupation to accidental transcontamination, such as children playing in a sandbox frequented at other hours by drug addicts or even road workers. working in the technical mouths of the roads. Unbeknownst to them, these people are at risk of death until AIDS is defeated.

Most of the past innovations in the field of safety devices have aimed to prevent this type of accident at the source of supply by offering manufacturers the greatest possible facility for bringing their productions of needles into conformity with the legislative provisions in force, if possible while satisfying the industrial and commercial constraints of the market.

These safety or protection devices and their various drawbacks will be discussed below. We will first of all cite the “summary” safety device such as a hood or an original cap not integrated into the needle, but designed as a removable removable accessory. It is a very technical piece, generally produced industrially by specialized manufacturers and sold in bulk and by weight. A rigid cap is designed to be removed before action and replaced after the operating procedure, at the operator's own risk.

We will then cite the security devices that have flourished since the early 90s. They have in common an inability to cover the plurality of needs or practices, for lack of a basic principle allowing to cover a full range of secure needles.

An example of such a known device is the needle which retracts inside the pump body of the syringe according to the action and the position of the piston during aspiration or injection. The engagement of the clutch at the needle anchor in the end of the pump body is actuated by different spring mechanisms. Some mechanisms are operated manually, others automatically. The realization requires a new engineering design of the industrial tool, and therefore very costly investments which thwart the response to the universal need for security. In a known concrete embodiment marketed by Becton-Dickinson, a cylindrical slide is mounted in translation on the body of the syringe. This however requires a specific syringe and relatively expensive production. Another safety device includes a shield which slides in translation on the body of the cannula or an extension in the form of an articulated leg, which implies in either case that the protection of the bevel is ensured by a consecutive action to a voluntary gesture by the operator. This type of protective device concerns intramuscular injections whose good operating practice requires frank gestures and energetic allowing deep penetration into the tissues, at an angle close to 90 °. The response to the need for security is therefore partial.

More recently, and in certain sophisticated inventions, the safety gesture has been broken down into two stages: firstly an insert with a spring effect is engaged when the needle is released until it stops; in a second step the stop notch is deactivated by a simple and precise gesture causing the relaxation of the spring effect, automatically followed by the programmed protection. The answer to the need for security is limited here to a short market segment.

We will see that the present invention aims to provide an integrated safety device which can adopt at least two positions which essentially depend on the mechanical properties of the material in the rest state and under the constraint of a simple gesture by the operator to promote its adoption by health workers without requiring major initiation or training campaigns.

Another object of the invention is to preserve the autonomy of the functions of the invasive element on the one hand, and to increase the coherence of all of its functions: intrusive function, manipulation function, integrated security function, this on the basis of a precise analysis of the operator's gestures, for one part, and on the economic analysis allowing the constitution of a range of injection instruments having to satisfy the multiple specific needs of good practice operative, for another part. Concerning the safety of injections, it is a question of contributing to its generalization. The goal is to offer a possible synergy between secure needle technology, a simplified mechanism for propelling therapeutic substances, all of which could constitute a new generation of injection devices forming individual packaged doses.

Yet another object of the invention, by the versatility of an anchoring function of a needle protection device, is also to cover the needs of the traditional needle market, as well as of future markets. new injection devices to be created. In all cases, the safety of health workers will be made less dependent on the limited flexibility of manufacturers of medical instruments.

The invention also aims to cover the market for original equipment cannulas on medical injection instruments, without any other design engineering. Based on the standard universal male-female Luer coupling, anchoring can be carried out both upstream of a short catheter and downstream of a pre-filled syringe or a medical instrument equipped with an original needle, such as a small diameter insulin or tuberculin syringe. For larger diameter syringes, particularly for pre-filled syringes made of glass or plastic, the object of proposing a protective device which can adapt to any geometry and to any size, in particular by being able to move as desired the place of anchoring on the injection device, and in particular upstream of a syringe pump body, without hampering the readability of the graduation. The same goes for insulin syringes, the users of which generally suffer from a decrease in visual acuity linked to diabetes: the object here is that the protective device can exercise a magnifying glass function by improving the readability of the graduation on the pump body, being reminded here of the capital importance of this graduation for the dosage of insulin.

The present invention aims secondly to provide a new container device capable of cooperating with a needle according to this standardized coupling and simultaneously performing at least one function of packaging an injectable substance (sterile containerization and preservation protected from air) and a propellant function of this substance through the needle.

The invention also aims to propose a device allowing the aspiration of bodily fluids for example for analysis.

The invention provides, according to a first aspect, a protection device for an invasive element of the needle type comprising a terminal tip, characterized in that it comprises a thin element produced in one piece, comprising an anchoring part in particular at invasive element remote from the point and a protective part of the point, the thin element having a shape such that it is capable of adopting two stable positions, a first in which the protective part covers the point, and a second in which the protective part is released from the tip and authorizes the invasion.

Preferred but non-limiting aspects of this device are the following: - The protective part includes a cradle for the tip of the invasive element, housing all of said tip. the thin element has, in its first position, a convex outer face and a concave inner face. the device comprises, between the protective part and the anchoring part, an actuating part allowing the device to pass from its first position to its second position.

- said actuating part is constituted by said convex outer face, capable of receiving pressure.

- the protective part, the anchoring part and the actuating part are made in one piece.

- The device is made by silicone molding.

- the device is transparent.

- The anchoring part comprises a strip cut from the material of the device and capable of enclosing a region for mounting the invasive element on a container for injecting or withdrawing fluid.

The invention also provides an invasive needle for injecting therapeutic liquids, removing bodily fluids, etc. characterized in that it comprises a protection device as defined above, fixed to it.

Advantageously, the needle is wrapped in the protection device.

The invention also provides a device for containing a fluid, capable of cooperating with an invasive element such as a needle, in particular for injecting a therapeutic liquid or for withdrawing a fluid. body, characterized in that it comprises a mounting part for the invasive element, defining a general axis of the device, and an envelope in one piece deformable essentially along said axis. Preferred but non-limiting aspects are as follows:

- The device comprises a peripheral helical rib ensuring the preferred deformability along said general axis. - the trajectory of the rib responds, in projection in a plane substantially perpendicular to the general axis, to the equation of a logarithmic spiral.

- the mounting part and the enclosure are made in one piece. - the envelope is coated on the inside with amorphous carbon.

- The device comprises in the mounting part a liquid outlet orifice provided with a cover capable of being perforated or moved by the inner end of a cannula attached to the device. the device further comprises an expulsion lug provided at a face of the envelope opposite to the mounting part and to penetrate therein to expel a fluid. - the fluid is a viscous gel.

The invention finally proposes an injection device comprising an invasive element such as a needle, a protection device as defined above mounted on the invasive element, and a container device as defined above. Preferably, the invasive element and the container device are assembled by standard Luer cones.

Other aspects, aims and advantages of the present invention will appear better on reading the following detailed description of a preferred embodiment thereof, given by way of non-limiting example and with reference to the accompanying drawings, in which: FIG. 1A is a top view of a needle fitted with a protective part of an injection device according to a first embodiment of the invention, the protective part being in a first position, FIG. 1B is a side view of a standard injection needle belonging to the injection device,

FIG. 1C is a side view of the needle and of the protective part, in the position of FIG. 1A,

FIG. 1D is a side view of the needle and of the protective part, in a second position,

FIG. 2 is a side view of a standard injection needle and a standard nozzle of an injection device,

FIG. 3 is a side view of an injection device of the syringe type and its needle, with a protective part similar to that of FIGS. 1A to 1D, FIG. 4A is a perspective view in profile of a part retaining and expelling an injection device according to the invention, FIG. 4B ^• is a partial front view of the part of FIG. 4A,

FIG. 4C is a view in axial section of the part of FIGS. 4A and 4B, at rest, FIG. 4D is a side view, in the compressed state, of the part of FIGS. 4A to 4C,

FIG. 5 illustrates graphically a preferred contour of a compressible zone of the part of FIGS. 4A to 4D, and FIGS. 6 and 7 are views in axial section of two variants of the retention and expulsion device.

Referring firstly to Figures 1A to 1D, there is shown a protective device 10 or casing here permanently associated with a short catheter. The casing can also be manufactured as a semi-finished product adaptable in particular to a short commercial catheter in place of the traditional protective cover thereof, whether this element is manufactured by the original manufacturer to be then assembled its short catheter or its injection devices equipped with an original equipment needle, or that this element is manufactured by an equipment manufacturer who adapts it to the original standard products of its customers or manufacturers suppliers. The casing 10 is a one-piece piece of transparent thermo-flexible plastic material intended to form an integral part of medical injection devices, whether short catheters, traditional syringes, including pre-filled syringes equipped with an original equipment needle or any other injection device of series IV, in particular a container device according to the invention as will be described later.

The design of the casing 10 is such that, firstly, on the intrusive side of the article for which it is intended, namely the sharp bevel of a needle, it ensures the protection of the cutting edge of the bevel, in all circumstances, against mechanical attack of the bevel before the first use. Second, after single use of the device, the casing, in the permanent rest position, obscures the aggressiveness of the bevel passively to avoid any injury, scratch or accidental puncture attributable to. the dirty tip of the needle. Third, in its design on the downstream side of the medical instrument for which it is intended, the casing has means for fixing to the body of the instrument, for example the pump body of a commercial syringe or the body of any other medical injection device, including short commercial catheters, thus ensuring by its adaptability wider distribution to all ranges of standard devices of series IV. It is a product concept with a maximum of degrees of freedom to promote the safety of injections in hospitals, during vaccination campaigns and during self-injections outside dispensaries.

Now in more detail, the housing 10 for needle has a shape ^general inspired by the shape of a manta ray which fins 12, 12 have a rounded at the ends. The front part 16 of the security device constitutes a shield which comes to marry and circumscribe the aggressiveness of the bevel 25 of the needle 24 without rubbing against it, thanks to the forces internal elastic of the body 11 of the part acting as a casing, this body being integral with two functional elements, namely the front part 16 or shield "and a base 14, the whole constituting a monobloc part produced by injection. The material used for this part 10 is for example a translucent silicone, such as that used for the manufacture of suction cups or teats for baby bottles.

Depending on the length of the injection cannula, the dimensions of the casing 10 are adapted to the distance between the shield and the base of the cannula.

By default, that is to say without the voluntary intervention of the operator, the protective shield 16 mechanically follows the bevel 25. It will be mentioned here that according to the clinical studies and the ^' field tests carried out years in the United States, the character of automatic protection and independent of the operator's will is best appreciated to meet security needs without modifying professional gestures.

As we will see, this protective device is used with simple gestures, carried out by the dominant hand of the operator, safely during the operating procedure, without the need for cooperation of both hands to accomplish the entirety of this act. Once the wings 12, 12 are raised symmetrically and pinched together between the thumb and the operator's index finger, in the vertical plane defined by the cannula 24, the shield 16 is rolled up to release the point 25 of the needle 24.

Security is thus ensured by default. Coordination between the two hands is not necessary to performing the operating procedure, which limits the risk of accidental sting. The non-dominant hand, that more generally exposed to accidents, always remains outside the radius of action of the tip 25. This safety device exclusively exploits the physical properties of the plastic material of the casing 10: the fact of symmetrically turning the fins 12 from horizontal to vertical, the curvature of said casing which changes from a concave shape to a convex shape with the crossing of a state of instability changes.

The mechanical characteristic of the invention, concerning the protection device, is based on the elasticity of the part 10. These forces are dormant when the part 10 is at rest, like a concave lens. These constraint forces come into action under the impulse imparted by the operator's natural gesture when he grabs the instrument. The operator rolls up the symmetrical fins 12 of the casing, and clamps them firmly substantially in the vertical plane passing through the cannula 24. The cannula is then completely released, ready to incise the skin and to penetrate at the angle which the operator. The handling is very precise and the operator's hands are, thanks to the casing 10, out of the field of action of the tip of the needle. Visibility is also excellent.

We will describe in a concrete example the shield-base connection for a safety casing intended to equip, as an intrusive part, a short commercial catheter such as a standard hypodermic needle of caliber 23 x 1, which corresponds to a cannula of useful length 25 mm and diameter 0.60 mm. The safety casing 10 cooperates at its base 14 with the female Luer cone 22 of the short catheter 20.

In other embodiments such as the case of original equipment needles, an adaptation of the base of the safety device, for example to the pump body of a traditional syringe (see FIGS. 2 and 3) is carried out in order to satisfy certain normative constraints. such as the transparency and the mandatory readability of the graduation on said pump body.

More particularly, the casing 10 is formed from a single piece of plastic material such as for example a transparent silicone, the geometric shape of which is for example, at least approximately, generated by the equation of a hyperbolic spiral.

The casing thus has the general appearance of a thin and flexible lens, the length of which is slightly greater than the total length of the needle 20 (cannula + Luer cone) with which the casing 10 must cooperate, and its greater width. is about three-quarters of its length. Its surface is smooth and non-slip. The thickness of the casing can be constant or variable depending on the density of the material used. The casing has its two lateral regions 12 forming fins, the ends of which are thinned up to the limit of the functional convexity perimeter of the flexible lens. This provision, detailed below, relates more particularly to a variant of the delivery position in accordance with the constraints of sterile packaging of the finished product. Another of the properties of the form is to facilitate attachment to the patient's skin at the level of the device 10 for optimizing stability in the case of a permanent fixing.

For example, the casing 10 has in its geometric center a thickness which is twice the thickness at its outer edges 12. The thickness variation can be constant or in stages.

The shape of the part with respect to the horizontal plane is concave, so that the cannula 24 is placed in the horizontal plane of the concave shape like the string of an arc, at the intersection of this horizontal plane with the vertical plane defined by the cannula.

The monobloc casing 10 is naturally braced on the cannula, without constraint on the side of the bevel but with a firm anchoring on the Luer cone by its base 14. The top of the flying arch is located approximately at the intersection of the perpendicular from the middle of the cannula with a virtual line drawn on the vertical plane defined by the cannula. This virtual line forms an angle for example of 30 ° with the axis of the cannula, a value which determines the length L of the segment which connects the top of the casing in the rest position to the midpoint of the cannula. It is observed here that the top point of the casing 10 can, by design, be located upstream or downstream from the midpoint of the cannula without modifying the functionality of the part. On the contrary, the position of this point becomes a design parameter to optimize the shape of the part according to different constraints.

A simple pressure of the operator's index finger on the top of the casing causes a lever effect on the shield 16, which, straightening, releases the point 25 of the needle 24. Concomitantly the fins of the casing spontaneously lift symmetrically, following the inversion of the curvature of the casing, thus offering a solid grip on the thumb and forefinger of the dominant hand of the operator. Other stress forces of the material of the casing 10 can come into action to continue the movement of straightening the shield and completely release the needle (see FIG. 1D). These forces ensure a stable position of the safety device for the needs of the operating procedure. These are in particular the forces opposing the pressure of the flange 14 which forms the base of the casing. These forces cooperate in aligning the casing 10 vertically with the needle. The base 14 which ensures the securing function of the safety device 10 is a notch or light arranged in the body of the part 10 and formed for example by two parallel incisions 141, 142 in the form of a blade line passing through in part the entire thickness of the material of the casing, so as to release a strip of material.

The shape of the strap is that of a rectangular parallelepiped, constituting a flange which comes to tighten elastically on the Luer cone 22 of the needle. The upstream blade line 141 is positioned at a small distance

(typically 1 mm) from the outer edge of the casing 10 opposite the bevel 25. The downstream blade line 142 is positioned for example 3 mm away from the upstream blade line 141.

The two parallel blade lines form an angle of 90 ° with the long axis of the housing 10, so as to provide a passage for the body of the Luer cone while leaving the flange 14 completely secured to the casing by the short sides of the rectangular parallelepiped.

The length of each blade line is close to the outside diameter of the Luer cone 22, measured at the right conical section located at the level of the blade line considered. The internal surface of the strap or flange 14, in contact with the material to which it is secured, in this case the external surface of the Luer cone, is a surface having, where appropriate, physical characteristics which increase the force of adhesion between the two parts under the sole pressure of the elasticity of the material under tension.

The casing 10 is thus secured to the Luer cone while the casing covers the assembly of the needle 24. As regards the shield 16 protecting the bevel 25, it is formed from three elements which are an integral part of the material of the casing. These three elements are arranged so that the tip of the needle can neither pierce the shield nor avoid it. The first element is a frontal dam of material 161 in the axis of the tip of the cannula. The dimensions of this part (length, width, height and thickness) are sufficient to offer serious resistance to the aggressiveness of the tip of the cannula. The other two elements 162 arranged symmetrically on either side of the axis of the cannula form an open channel, the edges of which are constituted by two prominences of material in the form of a half-moon to form a V-shaped beak, with the height of the V slightly greater than the length of the bevel 25 of the cannula. The internal spacing of the material prominences, at the base of the V is here about 1.2 mm, that is a sufficient spacing for frictionlessly accommodate the maximum diameter of the silicone cannula, which diameter here does not exceed 1.1 mm.

The V is formed by the two prominences of material 162 on the internal face of the casing, so that the point of the V is located substantially in alignment with the axis of the cannula 24 at a distance of approximately 1 mm upstream of the bevel and a distance of about 1mm + the length of the bevel 25 + thickness of the dike 161 of the extreme edge of the casing. The function of the V-shaped spout is to wedge the cannula to prevent the material of the casing, always more abrasive than soft steel, from undergoing movements likely to dull the bevel by friction, material against material, during the transport of the devices. injection systems fitted with the safety device. The shield 16 can be reinforced by a deposit, notably metallic, to increase its resistance to the aggressiveness of the tip of the cannula. In this case, the deposit is preferably secured to a stake (not shown) going from the beak of the shield 16 to the top of the casing 10 in the protective position in order to provide resistance to bending in the event of a frontal impact. As a variant, this resistance can be provided by a rib injected into the material of the casing 10.

A specific design of the needle part can be envisaged to ensure the function of striker aiming to release the injectable material located in the containment and injection element which will be described later, during coupling between the needle and this element. For this purpose, as will be seen, this pre-filled containment element is provided with a plug or cover in the form of a circular flexible membrane crimped by a process suitable for the downstream end of the male Luer cone of this item. The diameter of the circular membrane, the center of which is coaxial with the two coupled devices, is approximately 0.8 mm greater than the outside diameter of the end of the male Luer cone and 0.2 mm less than the inside diameter of the Luer cone needle female 22. The coupling causes tension in the diaphragm and reinforces the Morse entrapment of the male and female organs. Penetration is limited by the clamping forces to approximately 4 or 5 mm. Halfway through the stretched membrane is exposed to a striker disposed inside the female Luer cone coaxially with the two devices. This striker is in fact the end 27 of the cannula opposite its invasive tip, which is preferably cut with a short bevel. The cannula 24 is crimped to the female Luer cone 22 so that, downstream of crimping or bonding up to the end of the intrusive bevel 25, its useful length corresponds to the standard. Upstream, inside the female Luer cone, its useful length is calculated so that the end of the short bevel of the striker meets the membrane of the seal of the containment element substantially halfway through penetration following the coupling of the two devices, approximately 2 mm from the mouth of the female Luer cone. This specific design of the compression element allows the external dimensions of the Luer cone, particularly its length, to be arranged to offer a better grip, facilitating the assembly of the male and female cones and the percussion of the needle and the membrane with minimum effort and impact. A safety device according to the invention as described above allows traditional injection devices to co-exist with new ones. injection devices based on needle penetration.

The other part of the injection device, forming an element for restraining and expelling the therapeutic substance to be delivered, is based on the principle of an individual mono-dose pre-filled cartridge for single use. To the extent that this element is destroyed after a single, single and first use, certain practices bordering on vaccine safety will tend to disappear. To accelerate the eradication of these practices or at least contribute to it, it is essential that the cost of manufacturing such an element is as low as possible, and in particular less than or equal to the cost of use by traditional instrument. This equation is certainly not realistic in the cases of programmed systematic re-use, but arbitration becomes all the more favorable in economies of shortage.

It is with the aim of making the said arbitration as favorable as possible that this part of the invention has been developed, by making all the dispensary functions contribute to the objective of safety of medical and particularly vaccine injections. The dispensary functions in question are of three different and complementary natures: intrusive functions, functions for conditioning therapeutic substances, and logistical functions.

The contribution of intrusive functions to injection safety has been explained above.

In the following, we will describe packaging functions, namely the shape and mechanical characteristics of the container element and, below, certain logistical aspects which relate to the capacities of the injection device which is the subject of the invention to satisfy dispensary functions such as sterility, availability in emergency and the cold chain. The container element is thus a prefilled, single-dose injectable cartridge whose downstream end consists of a male Luer cone intended to match the female Luer cone of the specific short catheter 20 as described above, this cartridge being sealed by a thin and flexible membrane.

The geometric shape of the peripheral turns of this element is advantageously generated by the equation in polar coordinates of a logarithmic spiral, configured so that the volume of the container is preferably equal to the dose prescribed for vaccine injections, for example 0 , 5 ml, 1 ml or 1.5 ml.

It is believed that the hydrodynamic properties of such a container are such that inside, a pressurized liquid is evacuated according to the turns with a swirl effect.

Such an arrangement makes it possible to save on a compression chamber provided with a piston. It is nevertheless desirable that the friction between the injectable substances and the surface of the walls of the container does not generate a significant pressure differential between the flow at the center of the device relative to the flows at the periphery.

To reduce this friction, it is advantageous to modify the dosage form of the injectable substance and its liquid excipient by adding, for example, a polymer which increases the viscosity of the injectable liquid. to the point of turning it into gel. The hydrophilic and hydrophobic properties of the gel can also be used in certain therapeutic applications. It is also advantageous to cover the internal walls of the container, preferably by a cold plasma technique, with a layer of amorphous carbon, this being particularly suitable if the container is made from polyethylene terephthalate (PET) or polycarbonate crystal, the mechanical properties of resistance to crushing allow regular deformation under the pressure of the thumb of the operator along the orthogonal axis of the device induced by the logarithmic spiral shape. The programmed deformation of the constituent material of the container subjected to the pressure of the thumb of the operator takes place between two stable positions of the injection device, namely the position illustrated on 4A where the turns are expanded by the stress of the material that the shape of the mold imprints on the impression during injection, and the position of FIG. 4D where the turns are crushed following the deformation of the material by the vertical pressure of the thumb of the operator. The stability of the second position depends on the thickness of the walls of the container, this thickness being calculated so that the resilience of the material does not cause a return movement such as to generate a post-operative aspiration.

Advantageously, the container 40 is designed so that at constant pressure of the operator's thumb on the rear base 41, the progressive crushing of the turns is substantially linear, with a regular and preferably essentially constant flow.

In order to avoid the rotation of the container around its axis during the application of the pressure of the thumb, two fins 46 arranged symmetrically in the exit region of the container, in the dead space between the male Luer cone 42 and the base of the container, have the function of facilitating the grip of the instrument between the index and the middle finger of the dominant hand of the operator, so that the base of the container undergoes without sliding under the thumb an adequate pressure and adapted to the resistance of the injection, and that this pressure exerted in the axis of the device is well distributed over the entire surface of the base 41. In order to adapt the injection to good operating practice in medical matters, several design variants - are planned. These variants take into account the medical experience based on injection by syringes fitted with a compression chamber and a plunger with or without a rubber plunger.

In particular, the study of the dynamics of fluids under pressure during the reduction in diameter between the flow of liquid in the cylinder of the syringe and the flow in the core of the needle demonstrated that it caused turbulence, which have been the subject of mathematical modeling. This results in a minimum reduction in the internal diameter of the syringes (in particular for the injection of insulin, tuberculin, etc.) and a thin-walled cannula technology to offer, with equal external diameter, a maximum internal diameter for the cannulas. Manufacturing techniques for the syringe rubber plunger have also been adapted to increase the seal while reducing the friction against the walls of the cylinder of the compression chamber. The injectable liquid is subjected during the injection to a constant and linear pressure under the effect of the translation of the piston actuated by the pressure of the thumb of the operator. The compression chamber always remaining cylindrical, the compressed liquid is expelled towards the outlet according to a constant diameter. Now back to the invention, the funneling effect of the conical shape of the container 40 induces another fluid dynamics according to a different mathematical model. More precisely, the reduction in friction and the increase in the viscosity of the injectable substance reduces turbulence to the extent that the cavity of the container is completely filled during automatic packaging.

Now concerning intravenous injections, we know that the slightest air bubble inside the container will prevent injection if this air bubble cannot be completely evacuated. Now with reference to FIG. 6, provision can be made for the injectable substance to be in the form of a gel at the maximum of its viscosity, and for the injectable dose to sit inside the male Luer cone of the container 42. This concentrated dose, the size for example of a grain of wheat, is intended to be propelled by a lug 43 formed integrally with the container, and which closely matches the cavity containing this dose. The lug 43 is an integral part of the base and is positioned in the axis of the device. The thumb pressure of the operator evacuates the air contained in the device 40 by lateral vents 45 arranged at the base of the device so that the volume of air evacuated under pressure offers little or no resistance. Consequently, only the resistance to deformation of material opposes the pressure of the thumb of the operator and the propulsion of the injectable substance takes place under the mechanical pressure of the lug 43. Advantageously, the lug 43 can be dimensioned to get stuck in the expulsion pipe after injection, to guarantee single use. Another variant of the container, designed to take a sample of body fluid, is represented in FIG. 7 of the drawings. It is distinguished by the mechanical characteristics of the material, namely a thermo-flexible medical plastic. The container here again has a lug 43, but which here has the function of closing, in the compressed position, the cone Luer maie, so as to maintain the interior chamber of the container 40 in compression during the coupling of the needle 20 on the container before the intervention. This lug 43 is designed so that the device is sealed and prevents outside air from being able to enter the cannula during the coupling operation. This container 40 intended for punctures of body fluids is thus delivered in the compression position. Maintaining this stable position is guaranteed by a sealed cap which advantageously replaces the membrane forming a seal described above.

It will be noted here that a particular property of PET is a deficit in thermal conduction compared to glass. This conduction deficit is estimated at 25%. According to another aspect of the invention, provision is made for the deposition inside the cavity of the container of an amorphous carbon layer. This deposition, preferably carried out by surface treatment, increases the seal against peripheral gas exchanges. It is also supposed to increase the deficit of thermal conduction compared to glass, but such a property can become completely advantageous in the cases of non respect of the cold chain, until landing with the accidental or programmed breaks of this chain of the cold, especially in parts of the world where dispensary equipment leaves something to be desired.

The use of an internal coating of amorphous carbon has other advantages: firstly, its rigidity gives better resistance to crushing of the container, which reduces the risk of accidental discharge; in addition, the deformation of the container carried out for injection causes a loss of integrity (rupture) of this coating of amorphous carbon, and guarantees the functionality of single use by rendering the container unusable a second time.

Back to the protection device described above, provision can be made for the casing 10 to be made of a material which is sufficiently malleable so that at its outer edges, it can be wound around the cannula 20 and wrap the latter before the 'the whole is packaged for marketing, for example in a blister. This arrangement does not significantly modify the existing automatic blistering process.

Finally, according to another variant, provision may be made to produce the entire injection device (at except the needle), namely the container and the protective device, in one piece, for example made of silicone. This is particularly applicable when the shelf life of the product to be injected is not critical.

Of course, many other variants and modifications can be made to the invention.

1. Protective device for an invasive element of the needle type comprising a terminal tip, characterized in that it comprises a thin element made in one piece, comprising an anchoring part in particular to the invasive element at a distance from the tip and a tip protection part, the thin element having a shape such that it is capable of adopting two stable positions, a first in which the protective part covers the tip, and a second in which the protection is released from the point and allows invasion.

2. Device according to claim 1, characterized in that the protective part comprises a cradle for the tip of the invasive element, housing all of said tip.

3. Device according to one of claims 1 and 2, characterized in that the thin element has, in its first position, a convex outer face and a concave inner face.

4. Device according to one of claims 1 to 3, characterized in that it comprises, between the protective part and the anchoring part, an actuating part allowing the device to pass from its first position to its second position.

5. Device according to claims 3 and 4 taken in combination, characterized in that said part

Claims

actuation consists of said convex outer face, capable of receiving pressure.

6. Device according to one of claims 4 and 5, characterized in that the protective part, the anchoring part and the actuating part are made in one piece.

7. Device according to claim 6, characterized in that it is made by silicone molding.

8. Device according to claim 6 or 7, characterized in that it is transparent.

9. Device according to one of claims 1 to 8, characterized in that the anchoring part comprises a strip cut in the material of the device and capable of enclosing a region for mounting the invasive element on a container for the injection or fluid withdrawal.

10. Invasive needle for injecting therapeutic fluids, removing bodily fluids, etc. characterized in that it comprises a device according to one of claims 1 to 9 attached to it.

11. Needle according to claim 10, contained in a package, characterized in that it is wrapped in the protection device.

12. Device for containing a fluid, capable of cooperating with an invasive element such as a needle in particular for injecting a therapeutic liquid or for withdrawing a body fluid, characterized in that it comprises a mounting part for the invasive element, defining a general axis of the device, and an envelope in one piece deformable essentially along said axis.

13. Device according to claim 12, characterized in that it comprises a helical peripheral rib ensuring the preferred deformability along said general axis.

14. Device according to claim 13, characterized in that the trajectory of the rib responds, in projection in a plane substantially perpendicular to the general axis, to the equation of a logarithmic spiral. •

15. Device according to one of claims 12 to 14, characterized in that the mounting part and the envelope are made in one piece.

16. Device according to one of claims 12 to 15, characterized in that the envelope is coated internally with amorphous carbon.

17. Device according to one of claims 12 to 16, characterized in that it comprises in the mounting part a liquid outlet orifice provided with a cover capable of being perforated or displaced by the inner end of a cannula attached to the device.

18. Device according to one of claims 12 to 17, characterized in that it further comprises a lug expulsion provided at a face of the envelope opposite to the mounting part and to penetrate therein to expel a fluid.

19. Device according to claim 18, characterized in that the fluid is a viscous gel.

20. Injection device, characterized in that it comprises an invasive element such as a needle, a protection device according to one of claims 1 to 9 mounted on the invasive element, and a device according to one from claims 12 to 19.

21. Device according to claim 20, characterized in that the invasive element and the container device are assembled by standard Luer cones.